Brazil’s health regulator Anvisa has authorised the registration of two liraglutide-based generics, paving the way for broader access to essential treatments for type 2 diabetes and obesity, though market entry remains subject to pricing and prescription regulations.
Brazil’s health regulator has cleared two generic medicines based on liraglutide, a drug used to treat type 2 diabetes and obesity, in a move that could broaden access to GLP-1-based treatment in the country. According to Metrópoles, the approvals were granted by Anvisa to EMS and published in the federal gazette on Tuesday, September 8, 2026.
The newly registered products are injectable solutions containing 6 mg/mL of liraglutide for under-the-skin use, supplied in different pen and cartridge formats. Their registration is valid until 2036, while each batch will have an 18-month shelf life. EMS has already used similar regulatory pathways for earlier liraglutide products, one aimed at weight management and the other at diabetes control, reflecting the fact that the same active ingredient can be prescribed for different conditions under separate dosing guidance.
Liraglutide works by acting on GLP-1 receptors, helping the body release insulin when blood sugar is high, slowing stomach emptying and increasing satiety. Clinical studies cited by Metrópoles suggest average weight loss of about 8% over a year. The drug has been used in Brazil for more than a decade and is already familiar to patients through branded medicines on the market.
The approvals do not mean the drugs will reach pharmacies immediately. Brazil’s medicines pricing authority, CMED, still has to set the maximum sale price. In addition, sales of this class of medication now require the physical retention of a prescription, a tighter rule introduced in 2025 after concerns about unsupervised use. The latest clearance also follows a mixed regulatory year for GLP-1 medicines in Brazil: in April, Anvisa rejected registration requests for three semaglutide and liraglutide products over technical shortcomings, while in May and August it approved several semaglutide-based pens for diabetes and obesity.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
